Medical device with sealing assembly

ABSTRACT

Medical devices and methods for making and using medical devices are disclosed. An example system for delivering an implantable medical device includes a handle member including a seal assembly, wherein the seal assembly includes a turnbuckle assembly including a stationary member and a cap coupled to the stationary member. Further, the stationary member is coupled to an inner member and the cap is coupled to an exoskeleton disposed along an outer surface of the inner member. Additionally, the cap is designed to shift relative to the stationary member such that the exoskeleton is put in compression.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 toU.S. Provisional Application Ser. No. 62/500,990, filed May 3, 2017, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing medical devices. More particularly, the present disclosurepertains to medical devices including a seal assembly designed toprevent fluid leakage within the medical device.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, intravascular use. Some of these devicesinclude guidewires, catheters, and the like. These devices aremanufactured by any one of a variety of different manufacturing methodsand may be used according to any one of a variety of methods. Of theknown medical devices and methods, each has certain advantages anddisadvantages. There is an ongoing need to provide alternative medicaldevices as well as alternative methods for manufacturing and usingmedical devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices. An example system for delivering animplantable medical device includes a handle member including a sealassembly, wherein the seal assembly includes a turnbuckle assemblyincluding a stationary member and a cap coupled to the stationarymember. Further, the stationary member is coupled to an inner member andthe cap is coupled to an exoskeleton disposed along an outer surface ofthe inner member. Additionally, the cap is designed to shift relative tothe stationary member such that the exoskeleton is put in compression.

Alternatively or additionally to any of the embodiments above, whereinthe cap is designed to shift distally with respect to the stationarymember.

Alternatively or additionally to any of the embodiments above, whereinthe exoskeleton includes a plurality of discrete segments engaged withone another, and wherein shifting the cap distally compresses thediscrete segments together.

Alternatively or additionally to any of the embodiments above, whereinthe cap member is threadedly engaged with the stationary member.

Alternatively or additionally to any of the embodiments above, furthercomprising a hypotube positioned along the inner member, wherein thehypotube is positioned between the cap and the exoskeleton.

Alternatively or additionally to any of the embodiments above, whereinthe cap includes a protrusion configured to engage a proximal portion ofthe hypotube.

Alternatively or additionally to any of the embodiments above, whereinthe cap includes a first seal, and wherein the first seal is disposedalong an outer surface of the hypotube.

Alternatively or additionally to any of the embodiments above, whereinthe stationary member includes a distal tip region configured to engagea proximal portion of the inner member.

Alternatively or additionally to any of the embodiments above, whereinthe stationary member includes a recessed region, and wherein therecessed region is designed to mate with a protrusion in the handle.

Alternatively or additionally to any of the embodiments above, whereinthe stationary member is configured to prevent the inner member fromshifting with respect to the handle.

Another example system for delivering an implantable medical deviceincludes:

a handle member including a seal assembly, wherein the seal assemblyincludes:

-   -   a first actuating assembly, wherein the first actuating assembly        is configured to receive a deployment sheath;    -   a second actuating assembly, wherein the second actuating        assembly is configured to receive an actuating shaft; and    -   a turnbuckle assembly including a cap and a stationary member;

wherein the turnbuckle is configured to compress an exoskeletonpositioned along an inner member;

wherein the inner member is disposed within a portion of the deploymentsheath.

Alternatively or additionally to any of the embodiments above, whereinthe cap is designed to shift distally with respect to the stationarymember.

Alternatively or additionally to any of the embodiments above, whereinthe exoskeleton includes a plurality of discrete segments engaged withone another, and wherein shifting the cap distally compresses thediscrete segments together.

Alternatively or additionally to any of the embodiments above, whereinthe cap member is threadedly engaged with the stationary member.

Alternatively or additionally to any of the embodiments above, furthercomprising a hypotube positioned along the inner member, wherein thehypotube is positioned between the cap and the exoskeleton.

Alternatively or additionally to any of the embodiments above, whereinthe cap includes a protrusion configured to engage a proximal portion ofthe hypotube.

Alternatively or additionally to any of the embodiments above, whereinthe cap includes a first seal, and wherein the first seal is disposedalong an outer surface of the hypotube.

Alternatively or additionally to any of the embodiments above, whereinthe stationary member includes a distal tip region configured to engagea proximal portion of the inner member.

Alternatively or additionally to any of the embodiments above, whereinthe stationary member includes a recessed region, and wherein therecessed region is designed to mate with a protrusion in the handle.

An example method of manufacturing a medical device includes:

coupling a catheter shaft to a handle member, wherein the catheter shaftincludes a liner and an exoskeleton disposed over a portion of theliner;

coupling a turnbuckle to the handle member, wherein the turnbuckleincludes a cap coupled to the exoskeleton and a stationary membercoupled to the liner; and

actuating the turnbuckle to compress the exoskeleton along the liner.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is a side view of an example medical device system;

FIG. 2 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 3 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 4 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 5 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 5A is a partial cross-sectional view of a portion of an examplemedical device delivery system along line 5A-5A of FIG. 5;

FIG. 5B is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 6 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 7 is a partial cross-sectional view of a portion of an examplemedical device delivery system;

FIG. 8 is a partial cross-sectional view of a portion of an examplemedical device delivery system.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the disclosureto the particular embodiments described. On the contrary, the intentionis to cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent throughout the world. Traditionally, treatment of thecardiovascular system was often conducted by directly accessing theimpacted part of the body. For example, treatment of a blockage in oneor more of the coronary arteries was traditionally treated usingcoronary artery bypass surgery. As can be readily appreciated, suchtherapies are rather invasive to the patient and require significantrecovery times and/or treatments. More recently, less invasive therapieshave been developed. For example, therapies have been developed whichallow a blocked coronary artery to be accessed and treated via apercutaneous catheter (e.g., angioplasty). Such therapies have gainedwide acceptance among patients and clinicians.

Some relatively common medical conditions may include or be the resultof inefficiency, ineffectiveness, or complete failure of one or more ofthe valves within the heart. For example, failure of the aortic valve orthe mitral valve can have a serious effect on a human and could lead toserious health condition and/or death if not dealt with properly.Treatment of defective heart valves poses other challenges in that thetreatment often requires the repair or outright replacement of thedefective valve. Such therapies may be highly invasive to the patient.Disclosed herein are medical devices that may be used for delivering amedical device to a portion of the cardiovascular system in order todiagnose, treat, and/or repair the system. At least some of the medicaldevices disclosed herein may be used to deliver and implant areplacement heart valve (e.g., a replacement aortic valve, replacementmitral valve, etc.). In addition, the devices disclosed herein maydeliver the replacement heart valve percutaneously and, thus, may bemuch less invasive to the patient. The devices disclosed herein may alsoprovide a number of additional desirable features and benefits asdescribed in more detail below.

The figures illustrate selected components and/or arrangements of amedical device system 10, shown schematically in FIG. 1 for example. Itshould be noted that in any given figure, some features of the medicaldevice system 10 may not be shown, or may be shown schematically, forsimplicity. Additional details regarding some of the components of themedical device system 10 may be illustrated in other figures in greaterdetail. A medical device system 10 may be used to deliver and/or deploya variety of medical devices to a number of locations within theanatomy. In at least some embodiments, the medical device system 10 mayinclude a replacement heart valve delivery system (e.g., a replacementaortic valve delivery system) that can be used for percutaneous deliveryof a medical implant 16 (shown in the detailed view of FIG. 1), such asa replacement/prosthetic heart valve. This, however, is not intended tobe limiting as the medical device system 10 may also be used for otherinterventions including valve repair, valvuloplasty, delivery of animplantable medical device (e.g., such as a stent, graft, etc.), and thelike, or other similar interventions.

The medical device system 10 may generally be described as a cathetersystem that includes an outer sheath 12, an inner catheter 14 extendingat least partially through a lumen of the outer sheath 12, and a medicalimplant 16 (e.g., a replacement heart valve implant) which may becoupled to the inner catheter 14 and disposed within a lumen of theouter sheath 12 during delivery of the medical implant 16. In someembodiments, a medical device handle 17 may be disposed at a proximalend of the outer sheath 12 and/or the inner catheter 14 and may includeone or more actuation mechanisms associated therewith. In other words,one or more tubular members (e.g., the outer sheath 12, the innercatheter 14, etc.) may extend distally from the medical device handle17. In general, the medical device handle 17 may be designed tomanipulate the position of the outer sheath 12 relative to the innercatheter 14 and/or aid in the deployment of the medical implant 16.Additionally, in some examples the outer sheath 12 of medical devicesystem 12 may include a curved portion 13. While FIG. 1 shows the curveof the outer member 12 lying within the plane of the page, otherconfigurations are contemplated. For example, configurations in whichthe curve of the outer member extends out of the page are contemplated.

In use, the medical device system 10 may be advanced percutaneouslythrough the vasculature to a position adjacent to an area of interestand/or a treatment location. For example, in some embodiments, themedical device system 10 may be advanced through the vasculature to aposition adjacent to a defective native valve (e.g., aortic valve,mitral valve, etc.). Alternative approaches to treat a defective aorticvalve and/or other heart valve(s) are also contemplated with the medicaldevice system 10. During delivery, the medical implant 16 may begenerally disposed in an elongated and low profile “delivery”configuration within the lumen and/or a distal end of the outer sheath12, as seen schematically in FIG. 1, for example. Once positioned, theouter sheath 12 may be retracted relative to the medical implant 16and/or the inner catheter 14 to expose the medical implant 16. In someinstances, the medical implant 16 may be self-expanding such thatexposure of the medical implant 16 may deploy the medical implant 16.Alternatively, the medical implant 16 may be expanded/deployed using themedical device handle 17 in order to translate the medical implant 16into a generally shortened and larger profile “deployed” configurationsuitable for implantation within the anatomy. When the medical implant16 is suitably deployed within the anatomy, the medical device system 10may be disconnected, detached, and/or released from the medical implant16 and the medical device system 10 can be removed from the vasculature,leaving the medical implant 16 in place in a “released” configuration.

It can be appreciated that during delivery and/or deployment of animplantable medical device (e.g., the medical implant 16), portions ofthe medical device system (e.g., the medical device system 10) may berequired to be advanced through tortuous and/or narrow body lumens.Therefore, it may be desirable to utilize components and design medicaldelivery systems (e.g., such as the medical device system 10 and/orother medical devices) that reduce the profile of portions of themedical device while maintaining sufficient strength (compressive,torsional, etc.) and flexibility of the system as a whole.

FIG. 2 illustrates the medical device system 10 in a partially deployedconfiguration. As illustrated in FIG. 2, the outer sheath 12 of themedical device system 10 has been retracted in a proximal direction to aposition proximal of the medical implant 16. In other words, the outersheath 12 has been retracted (e.g., pulled back) in a proximal directionsuch that it uncovers the medical device implant 16 from a compact,low-profile delivery position to a partially-deployed position.

In at least some examples contemplated herein, the medical deviceimplant 16 may be designed to self-expand once released from under theouter sheath 12. However, as shown in FIG. 2, the medical device system10 may be designed such that the implant 16 may be restricted fromexpanding fully in the radial direction. For example, FIG. 2 showsmedical device implant 16 having a partially deployed position denotedas a length “L₁.”

FIG. 2 further illustrates that in some examples, the implant 16 mayinclude one or more support members 22 coupled to the proximal end 18 ofthe implant 16. Further, FIG. 2 illustrates that in some examples, theimplant 16 may include one or more translation members 24 coupled to thedistal end 20 of the implant 16. Additionally, in some examples (such asthat illustrated in FIG. 2), the translation members 24 and supportmembers 22 may work together to maintain the implant in apartially-deployed position after the outer sheath 12 has been retractedto uncover the implant 16. For example, FIG. 2 illustrates that thesupport members 22 may be designed such that the distal end of each ofthe support members 22 may be coupled to the proximal end of the implant16 and that the proximal end of each of the support members 22 may becoupled to the distal end of the inner catheter 14. For example, FIG. 2illustrates that the proximal ends of the support members 22 may beattached to a containment fitting 29 which is rigidly fixed to thedistal end of the inner catheter 14. It can be further appreciated thatin some instances, the support members 22 may be designed to limit theproximal movement of the proximal end 18 of the implant 16 relative tothe distal end of the inner catheter 14.

Additionally, the translation members 24 may be designed to translate ina distal-to-proximal direction such that the translation of thetranslation members (via operator manipulation at the handle, forexample) may “pull” the distal end 20 of the implant closer to theproximal end 18 of the implant 16.

For example, FIG. 3 illustrates the distal-to-proximal translation ofthe translation members 24. It can be appreciated that if the supportmembers 22 limit the proximal movement of the proximal end 18 of theimplant 16 while the translation members 24 are translated proximally,the implant 16 may both foreshorten (along the longitudinal axis of theimplant 16) and also expand radially outward. The foreshortening andradial expansion of implant 16 can be seen by comparing the shape andposition of the implant 16 in FIG. 2 to the shape and position of theimplant 16 in FIG. 3. The position of the implant 16 shown in FIG. 3 maybe described as a fully deployed positioned of the implant 16 (versusthe partially deployed positioned of the implant 16 shown in FIG. 2).Further, FIG. 3 depicts the length of the fully deployed implant 16 as“L₂”, whereby the distance L₂ is less than the distance L₁ shown in FIG.2.

Additionally, it can be appreciated that the translation members 24 maybe designed to be able extend in a proximal-to-distal direction suchthat they elongate (e.g., lengthen) the implant 16 (along itslongitudinal axis). In other words, the implant 16 may be able to shiftbetween a partially deployed position (shown in FIG. 2) and a fullydeployed position (shown in FIG. 3) through the translation (eitherproximal or distal) of the translation members 24 along the longitudinalaxis as the support members 22 limit the movement of the proximal end 18of the implant 16.

It should be noted that the above description and illustrationsregarding the arrangement, attachment features and operation of thesupport members 22 and the translation members 24 as they engage andfunction relative to the implant 16 is schematic. It can be appreciatedthat the design (e.g., arrangement, attachment features, operation,etc.) of the both support member 22 and the translation members 24 asthey relate and function relative to the implant 16 may vary. Forexample, it is possible to design, arrange and operate the translationmembers 24 and the support members 22 in a variety of ways to achievethe partial and full deployment configurations of the implant 16described herein.

In some examples, an operator may be able to manipulate the translationmembers 24 via the handle 17. For example, the handle 17 may include anactuation member designed to control the translation of the translationmembers 24. FIG. 2 illustrates that the handle member 17 may be coupledto the translation members 24 via an actuation shaft 30 and a couplingmember 28. Additionally, FIG. 2 further illustrates that a distal end ofactuation shaft 30 may be coupled to the proximal end of the couplingmember 28. Further, while not shown in FIG. 2, it can be appreciatedthat the actuation shaft 30 may extend within the entire length of theinner catheter 14 from the coupling member 28 to the handle member 17.

For purposes of discussion herein, the inner catheter 14 may also bereferred to as an inner member or liner 14. The liner 14 may include anumber of different features shown in the figures described herein. Forexample, the liner 14 may include a lumen 25. Further, the translationmembers 24, coupler 28, actuation shaft 30, tubular guidewire member 34(described below), and grouping coil 32 (described below) may bedisposed within the lumen 25. These are just examples. The inner liner14 may vary in form. For example, the inner liner 14 may include asingle lumen, multiple lumens, or lack a lumen.

As described above, FIG. 2 and FIG. 3 illustrate the translation oftranslation members 24 in a distal-to-proximal direction (which shortensand radially expands the implant 16, as described above). However, FIG.3 further illustrates that translation of the translation members 24 ina distal-to-proximal direction is accomplished by translation of theactuation shaft 30 and coupling member 28 within the lumen 25 of theinner catheter 14. For example, as the actuation shaft 30 is retracted(e.g., pulled proximally within lumen 25 of the inner catheter 14), itretracts the coupling member 28 proximally, which, in turn, retracts thetranslation members 24 in a proximal direction.

In some instances it may be desirable to maintain translation members 24in a substantially linear configuration as they are translated withinthe lumen 25 of the inner catheter 14. In some examples, therefore,medical device system 10 may include a component designed to limitand/or prevent the translation members 24 from twisting around eachother within the lumen 25 of the inner catheter 14. For example, FIG. 2and FIG. 3 illustrate a grouping coil 32 wound around the translationmembers 24 such that the grouping coil 32 maintains the translationmembers 24 in a substantially liner configuration (and thereby limitsand/or prevents the translation members 24 from twisting within lumen25) as the translation members 24 are translated through the lumen 25 ofthe inner catheter 14.

FIG. 2 and FIG. 3 further illustrate that the proximal end of thegrouping coil 32 may be positioned adjacent the distal end of thecoupling member 28 and that the distal end of the grouping coil 32 maybe positioned adjacent the distal end of the inner catheter 14. Inparticular, the distal end of the grouping coil 32 may be prevented fromextending distally beyond the distal end of the inner catheter 14 by thecontainment fitting 29. In other words, the distal end of the groupingcoil 32 may contact the containment fitting 29.

It can be further appreciated that the grouping coil 32 may bepositioned within the lumen 25 of the inner catheter 14 such that thegrouping coil 32 may elongate and shorten (e.g., a length of thegrouping coil may adjust) within the lumen 25 of the inner catheter 14.For example, as the coupling member 28 is translated in a proximaldirection (shown in FIG. 3 as compared to FIG. 2), the grouping coil 32may elongate while continuing to group and/or contain the translationmembers 24 in a substantially linear configuration.

FIG. 2 and FIG. 3 further illustrate that the medical device system 10may include a tubular guidewire member 34 extending within the lumen 25of the inner catheter 14. The tubular guidewire member 34 may include alumen which permits a guidewire to extend and translate therein. Inother words, the medical device system 10 may be advanced to a targetsite within a body over a guidewire extending within the lumen of thetubular guidewire member 34. Further, the tubular guidewire member 34may extend from the handle member 17, through the lumen 25 of the innermember 14, through the implant 16 and terminate at a nosecone 36.

As shown in FIG. 2 and FIG. 3, in some instances the inner catheter 14may include an exoskeleton 40 disposed along the outer surface of theinner catheter 14. The exoskeleton 40 may be positioned between theouter member 12 and the inner catheter 14. For example, the exoskeleton40 may be positioned between the inner surface of the outer member 12and the outer surface of the inner catheter 14. Additionally, a distalend 42 of the exoskeleton 40 may be rigidly fixed with respect to theend region 26 of the inner member 14. In some examples, the distal end42 of the exoskeleton 40 may be fixed directly to the inner member 14.In other examples, the exoskeleton 40 may be attached to a fitting (notshown) which is fixed directly to the inner member 14. In otherinstances, a containment fitting 29 (or other similar fitting) may beused to prevent the distal end 42 of the exoskeleton 40 from moving withrespect to the end region 26 of inner member 14.

The exoskeleton 40 may include a plurality of discrete members orarticulating links. For example, the exoskeleton 40 may include aplurality of bead members 41 and a plurality of barrel members 43. Otherdiscrete members are contemplated that may have differing shapes and/orconfigurations. In general, the discrete members (e.g., the bead members41 and the barrel members 43) are engaged with one another and aredesigned to increase the compression resistance, the tension resistance,or both of the inner catheter 14 while also affording a desirable amountof flexibility and kink resistance such that the inner catheter 14 canbe navigated through the anatomy. The bead members 41 and the barrelmembers 43 may be arranged in a number of different configurations alongthe inner catheter 14. In at least some instances, the bead members 41and the barrel members 43 alternate along the inner catheter 14. Otherarrangements and/or patterns are contemplated.

It can be appreciated from the above discussion that the outer member12, the inner shaft 14 (including the exoskeleton 40), the actuationshaft 30 (which is coupled to the translation members 24) and thetubular guidewire member 34 may all extend from a position adjacent themedical implant 16 to a position in which they enter the handle member17. For example, FIG. 4 illustrates that the outer sheath 12, the innershaft 14 (including the exoskeleton 40), the actuation shaft 30 (whichis coupled to the translation members 24) and the tubular guidewiremember 34 may extend from an example medical implant 16 (which may besimilar in form and function to the medical implant described above) andenter the distal end 45 of the handle member 17.

In some instances it may be desirable to design medical device system 10such that the inner member 14 has a different orientation with respectto outer member 12 than that shown in the illustrations of FIG. 2 andFIG. 3. For example, FIG. 4 illustrates the inner member 14 may berotated 90 degrees as compared to the inner member 14 shown in FIG. 2and FIG. 3. Further, rotation of the inner member 14 may also rotate theactuation shaft 30 and the tubular guidewire member 34 (positionedwithin lumen 25 of the inner member 14). For example, as shown in FIG.4, the actuation shaft 30 and the tubular guidewire member 34 have beenrotated 90 degrees (as compared to their configuration shown in FIG. 2and FIG. 3), and therefore, the tubular guidewire member 34 can beconceptualized as being positioned “behind” the actuation shaft 30 inthe illustration.

FIG. 4 further illustrates that in some examples the exoskeleton 40(described above) may further include a hypotube 44 positioned overinner member 14. The hypotube 44 may be aligned with the alternatingbead 41 and barrel 43 members of the exoskeleton 40. For example, insome instances the alternating bead 41 and barrel 43 components of theexoskeleton 40 may abut the hypotube 44 at a position which is distal tothe distal end 45 of the handle member 17. In other words, thetransition from the bead 41 and barrel 43 components of the exoskeleton40 to the hypotube 44 may occur outside of handle member 17. Further,the detailed view of FIG. 4 shows that a distal end 46 of the hypotube44 may be positioned adjacent to a bead or barrel component 41/43. Inother words, the distal end 46 of hypotube 44 may directly engage (e.g.,contact) a bead or barrel component 41/43 of the exoskeleton 40. As willbe discussed in greater detail below, the hypotube 44 may extend intoand terminate within the handle member 17.

It can be appreciated that actuation of the various components (e.g.,the outer member 12, the inner shaft 14, the actuation shaft 30 and thetubular guidewire member 34) described above may occur via a variety ofactuation mechanisms disposed in handle member 17. It can further beappreciated that the actuation mechanisms may function to move thevarious tubular components described above relative to one another.Further, each individual actuation mechanism may need to be fluidlysealed to prevent fluid leakage into portions thereof (includingcomponents residing therein) which may be damaged or contaminated bycontact with fluid.

FIG. 4 illustrates an example fluid sealing assembly 50. Fluid sealingassembly 50 may include an outer sheath seal assembly 52, a turnbuckleseal assembly 54, an actuation member seal assembly 56 and a guidewiremember seal assembly 58, each of which will be described in greaterdetail below. Outer sheath seal assembly 52 may include a luer lockflushing port 53. The luer lock flushing port 53 may include a checkvalve. It can be appreciated that each of the outer member 12, the innershaft 14 (including portions of the exoskeleton 40), the actuation shaft30 and the tubular guidewire member 34 may be coupled to one or more ofthe outer sheath seal assembly 52, the turnbuckle seal assembly 54, theactuation member seal assembly 56 and the guidewire member seal assembly58.

FIG. 5 illustrates an example outer sheath seal assembly 52. Forclarity, luer lock flushing port 53 is removed from the outer sheathseal assembly 52 illustrated in FIG. 5. Additionally, outer sheath sealassembly 52 may include a body 59. Additionally, body 59 may include apost 48 extending along in a direction parallel to the longitudinal axisof the handle member 17. The post 48 may include a cavity 63 into whicha proximal end of the outer member 12 may be inserted. Additionally, thepost 48 of body 59 may include a threaded region 60.

Outer sheath seal assembly 52 may be designed to seal the outer member12 while providing a passageway for the inner shaft 14, the hypotube 44,the actuation shaft 30 and the tubular guidewire member 34 (not visiblein FIG. 5) to extend therethrough. For example, FIG. 5 illustrates thatthe outer sheath seal assembly 52 may include an outer seal 51. Outerseal 51 may be an O-ring or other similar type seal. As shown in FIG. 5,the outer seal 51 may be positioned between an inner surface of the post48 of the body 59 and the outer surface of the outer member 12.

Additionally, the outer sheath seal assembly 52 may include a seal nut47. Seal nut 47 may include a threaded region 61. It can be appreciatedthat the seal nut 47 may be designed to mate with the post 48. Forexample, it can be appreciated that the seal nut 47 may be designed tothread onto (e.g., screw onto) the post 48 of the body 59.

FIG. 5 further illustrates that in some examples, the outer member 12may include a ferrule 49 which may be attached to the outer surface ofthe outer member 12. In some examples the ferrule 49 may be overmoldedonto the outer surface of the outer member 12. As illustrated in FIG. 5,the profile of the outer surface of the ferrule 49 may be designed tomate with a portion of the inner surface of the seal nut 47. It can befurther appreciated that the seal nut 47, the ferrule 49, the post 48and the outer seal 51 may operate cooperatively to prevent fluid fromleaking out of the outer sheath seal assembly 52. Specifically, rotationof the seal nut 47 onto the post 48 may translate the ferrule 49 in adistal-to-proximal direction, thereby compressing the outer seal 51 ontothe outer surface of the outer member 12.

FIG. 5 further illustrates that the seal assembly 52 may include athreaded back-up ring 57. The back-up ring 57 may be threadably engagedwith a mating threaded portion 62 of the body member 59. Threadedback-up ring 57 may be designed to compress a hypotube seal 55 onto thehypotube 44. For example, rotation of the back-up ring 57 onto the body59 may compress the hypotube seal 55 onto the outer surface of thehypotube 44. In at least some examples, the hypotube seal 55 may be anX-ring type seal, however, other seal configurations are contemplated.Utilizing an X-ring seal design for the hypotube seal 55 may reducefrictional forces upon the hypotube 44 in instances when the hypotube 44is translated through the hypotube seal 55.

It can be appreciated from the illustration in FIG. 5 and the abovediscussion that the outer member 12 may terminate within the outersheath seal assembly 52. Accordingly, it can be further appreciated thatactuation of the outer sheath seal assembly 52 may actuate (e.g., shift,translate, move, etc.) the outer sheath 12. While not expressly depictedin the figures, it can be appreciated that the handle 17 may include oneor more actuation mechanisms designed to actuate the outer sealingassembly 52, which may shift outer member 12 relative to the hypotube44, the inner member 14, the actuation shaft 30 and the tubularguidewire member 34. Actuation of the outer member 12 may uncover (e.g.,partially deploy) the medical device 16 as described above.

In some examples, the outer member 12 of the medical device system 10may include one or more features which are designed to orient the outermember 12 with the handle 17 in a specific configuration. For example,FIG. 5A illustrates a cross-section of the body 59 of an example sealingassembly 52, as discussed above. The body 59 may be similar in form andfunction the body 59 discussed above. As discussed above, the post 48may include a cavity 63 designed to accept the proximal end of anexample outer member 12 therein. As shown in FIG. 5A, the cavity 63 mayinclude an alignment recess 64, which, along with the overall profile ofthe cavity 63, is designed to align the curved portion 13 (shown inFIG. 1) of the outer member 12 with the body 59 (which, in turn, isultimately aligned with the handle 17). Additionally, FIG. 5B shows across-section of the proximal end region of an example outer member 12.FIG. 5B shows the outer member 12 may include a rib 65 molded onto theouter surface of the outer member 12. It can be appreciated that the rib65 may be aligned with the curved portion 13 of outer member 12. It canfurther be appreciated that the cross-sectional profile of the proximalend of the outer member 12 matches (e.g., mates with) the profile ofcavity 63 (which includes alignment recess 64), discussed above.

FIG. 6 illustrates an example turnbuckle seal assembly 54. Theturnbuckle seal assembly 54 may include a cap member 66 coupled to astationary member 67. Stationary member 67 may fixed relative to thehandle member 17. In other words, the stationary member 67 may includeone or more features that engage with handle 17, thereby preventing thestationary member 67 from moving with respect to the handle 17.

The cap member 66 may include a distal end 71 and a proximal end 82.Further, the cap member 66 may include a lumen 83 extending through aportion or the full length of the cap member 66. Further, the stationarymember 67 may include a distal end 68 and a proximal end 69. As shown inFIG. 6, the distal end 68 of the stationary member 67 may be insertedinto the lumen 83 of the cap member 66. Additionally, the stationarymember 67 may include one or more threads which are designed to matewith one or more threads positioned within the lumen 83 of the capmember 66. The engagement of the threaded portion of the stationarymember 67 and the threaded portion of the cap member 66 is shown in FIG.6 as a threaded region 84. As will be discussed in greater detail below,it can be appreciated that if the stationary member 67 remains fixedwith respect to the handle 17, rotation of the cap member 66 withrespect to the stationary member 67 may translate cap member 66proximally or distally (depending on the direction of rotation of capmember 66).

As shown in FIG. 6, the turnbuckle seal assembly 54 may include a firstturnbuckle seal 76 positioned between the cap member 66 and thestationary member 67. In at least some examples, the first turnbuckleseal 76 may be an X-ring type seal, however, other seal configurationsare contemplated.

The distal region 68 of the stationary member 67 may include one or moreattachment fingers 70. Attachment fingers 70 may be coupled to aproximal end of the inner member 14 (the inner member 14 is shown inFIG. 6 extending into the lumen 83 of the cap member 66). In at leastsome examples, the attachment fingers 70 of the stationary member 67 maybe engaged with a fitting 85 disposed along the proximal end of theinner member 14.

It can be appreciated that because the stationary member 67 is fixedwith respect to handle 17 and that the inner member 14 is engaged to thestationary member 67 (via the fitting 85 and attachment fingers 70),that the inner member 14 may be fixed with respect to the handle 17.Accordingly, it can be further appreciated from the above discussionthat rotation of the cap member 66 may translate the cap member 66proximally or distally relative to the inner member 14.

FIG. 6 further illustrates that the hypotube 44 may extend into andterminate within the cap member 66. Further, FIG. 6 shows that theproximal end of the hypotube 44 may include a hypotube fitting 75. Thehypotube fitting 75 may be securely fixed to the proximal end of thehypotube 44. Additionally, FIG. 6 shows that the hypotube fitting 75 mayengage with a protrusion 74 extending radially inward from the surfaceof the cap member 66. It can further be appreciated that rotation of thecap member 66 may translate the hypotube 44 in a proximal-to-distaldirection. The translation of the hypotube 44 in a proximal-to-distaldirection may also translate the distal end 46 of the hypotube 44 (shownin the detailed view of FIG. 4).

Further, as discussed above, the distal end of the hypotube 44 may beengaged with the bead and barrel components 41/43 of exoskeleton 40. Thedistal end of the bead and barrel components 41/43 may be fixed to thedistal end region of inner member 14 (discussed above with respect toFIG. 4). Therefore, proximal-to-distal movement of the hypotube 44 (viarotation of the cap member 66) may compress the individual bead andbarrel components 41/43 against one another along the outer surface ofthe inner member 14. Additionally, it can be further appreciated thatputting the exoskeleton 40 in compression may correspondingly place theinner member 14 (and components thereof) in tension.

FIG. 6 further illustrates that the actuation shaft 30 and the tubularguidewire member 34 (not shown, but understood as being positioned“behind” the actuation shaft 30 in the illustration) may enter thedistal end 71 of the cap member 66. For simplicity purposes, FIG. 6illustrates the actuation shaft 30 and the tubular guidewire member 34may engage and be coupled together via a coupling component 77 of theturnbuckle seal assembly 54. The coupling component 77 is designed tocouple the actuation shaft 30, the tubular guidewire member 34 and theactuation hypotube 78 together while permitting the tubular guidewiremember 34 to extend through at least a portion of the actuation hypotube78. For example, FIG. 6 illustrates the tubular guidewire member 34(depicted as dashed lines) extending within at least a portion of theactuation hypotube 78 (which is coupled to a proximal end of thecoupling component 77).

Similarly to that discussed with respect to the outer sealing assembly52 above, the distal region 71 of the turnbuckle sealing assembly 54 mayinclude a threaded back-up ring 72. Back-up ring 72 may be threadablyengaged with a mating threaded portion (not shown in FIG. 6) of capmember 66. Threaded back-up ring 72 may be designed to compress a secondturnbuckle seal 73 onto the hypotube 44. For example, rotation of theback-up ring 72 may compress the second turnbuckle seal 73 onto theouter surface of the hypotube 44. In at least some examples, the secondturnbuckle seal 73 may be an X-ring type seal, however, other sealconfigurations are contemplated. Utilizing an X-ring seal design for thesecond turnbuckle seal 73 may reduce frictional forces upon the hypotube44 in instances when the hypotube 44 is translated through the secondturnbuckle seal 73.

Additionally, the proximal region 69 of the stationary member 67 mayinclude a second threaded back-up ring 80. The second back-up ring 80may be threadably engaged with a mating threaded portion (not shown inFIG. 6) of the stationary member 67. Threaded back-up ring 80 may bedesigned to compress a third turnbuckle seal 81 onto the actuationhypotube 78. For example, rotation of the back-up ring 80 may compressthe third turnbuckle seal 81 onto the outer surface of the actuationhypotube 78. In at least some examples, the third turnbuckle seal 81 maybe an X-ring type seal, however, other seal configurations arecontemplated. Utilizing an X-ring seal design for the third turnbuckleseal 81 may reduce frictional forces upon the actuation hypotube 78 ininstances when the actuation hypotube 78 is translated through the thirdturnbuckle seal 81.

FIG. 7 illustrates the actuation member sealing assembly 56. Theactuation sealing assembly 56 may include a block member 92. The blockmember 92 may include a distal end 93, a proximal end 94 and a lumen 95extending therethrough. As illustrated in FIG. 7, the actuation hypotube78 may enter the lumen 95 at the distal end 93 of the block member 92.Further, the actuation hypotube 78 may extend through the lumen 95 ofblock member 92 and terminates in a threaded back-up ring 86.

Similar to that described above, the back-up ring 86 utilized in theactuation member seal assembly 56 may be threadably engaged with amating threaded portion (not shown in FIG. 7) of block member 92. Thethreaded back-up ring 86 may be designed to compress a first actuationseal 87 onto the actuation hypotube 78. For example, rotation of theback-up ring 86 may compress the first actuation seal 87 onto the outersurface of the actuation hypotube 78. In at least some examples, thefirst actuation seal 87 may be an X-ring type seal, however, other sealconfigurations are contemplated. Utilizing an X-ring seal design for thefirst actuation seal 87 may reduce frictional forces upon the actuationhypotube 78 in instances when the actuation hypotube 78 is translatedthrough the third turnbuckle seal 81.

As discussed above, the actuation hypotube 78 may be coupled to theactuation shaft 30 and the tubular guidewire member 34 via couplingcomponent 77. Further, the actuation shaft 30 may be coupled via coupler28 (shown in FIG. 2 and FIG. 3) to the translation members 24 while thetubular guidewire member 34 may be coupled to the nosecone 36.Therefore, it can be appreciated that actuation of block member 92 (and,correspondingly, the actuation hypotube 78 which is also coupled to thecoupling component 77) in a distal-to-proximal direction may actuateboth the translation members 24 and the nosecone 36 in adistal-to-proximal direction. As discussed above, the distal-to-proximalmovement of the translation members 24 may shift the implant 16 from itslength “L₁” illustrated in FIG. 2 to its length “L₂” illustrated in FIG.3.

In some instances, the distal-to-proximal movement of the block member92 may be controlled via an actuation handle (not shown in FIG. 7). Theactuation handle may include a pawl spring (not shown) that may engage aplurality of teeth 89 positioned along an outer surface of block member92. Engagement of the pawl spring with the plurality of teeth 89 maypermit the block member 92 to shift in a distal-to-proximal directionwhile also preventing the block member 92 from shifting in aproximal-to-distal direction.

FIG. 7 further illustrates that the actuation member sealing assembly 56may further include a guidewire hypotube 90. The guidewire hypotube 90may enter the lumen 95 of the block 92 at the distal end 93 of the blockmember 92. The guidewire hypotube 90 may be a stationary hypotube. Inother words, in some examples the guidewire hypotube 90 may rigidlyfixed relative (e.g., remain in a fixed position) relative to the block92 and the handle member 17. A second actuation seal 88 may bepositioned within the back-up ring 86. The threaded back-up ring 86 maybe designed to compress the second actuation sealing 88 onto theproximal guidewire tube 90.

Additionally, it can be appreciated that the guidewire hypotube 90 mayextend into a lumen (not shown in FIG. 7) of the actuation hypotube 78.Therefore, it further be appreciated that as the block member 92 isactuated (as discussed above), the actuation hypotube 78 may travelalong the outer surface of the guidewire hypotube 90. Additionally, thetubular guidewire member 34 may terminate at a position within the lumenof the guidewire hypotube 90. For example, FIG. 7 illustrates thetubular guidewire member 34 (depicted by dashed lines in FIG. 7)terminating in the lumen 96 of the guidewire hypotube 90.

FIG. 8 illustrates the guidewire tubing sealing assembly 58. Theguidewire sealing assembly 58 may include a threaded luer lock port 97.The luer lock port 97 may be rigidly fixed to the handle member 17.Further, the luer lock port 97 may include a lumen 98 extendingtherethrough.

As illustrated in FIG. 8, the luer lock port 97 may be attached to theproximal guidewire tube 90, which extends distally from the block 92 ofthe actuation member seal assembly 56, described above with respect toFIG. 7. In some examples, the proximal guidewire tube 90 may be welded(e.g., hermetically welded) to a portion of the luer lock port 97.

Additionally, it can be appreciated from FIG. 8 that the lumen 98 of theluer lock port 97 may be in fluid communication with the lumen 96 of theproximal guidewire tube 90. This fluid communication path may permit aguidewire (not shown) to be inserted through the luer lock port 97 andinto the lumen 96 of the proximal guidewire tube 90. Additionally, FIG.8 illustrates the actuation seal member assembly 56 including aguidewire sealing channel 99 having a diameter depicted as “X.” It canbe appreciated that in at least some examples, the diameter “X” may bedesigned to permit a guidewire to pass therethrough while also providingminimum clearance such that fluid is not permitted to pass therethrough.In other words, the clearance between the outer diameter of a guidewire(not shown) and the diameter “X” of the channel 99 may be designed toprevent fluid from leaking out of the luer lock port 97.

The materials that can be used for the various components of the medicaldevices and/or system 10 disclosed herein may include those commonlyassociated with medical devices. However, this is not intended to limitthe devices and methods described herein, as the discussion may beapplied to other components of the medical devices and/or systems 10disclosed herein including the various shafts, liners, componentsdescribed relative thereto.

The medical device 10 may be made from a metal, metal alloy, polymer(some examples of which are disclosed below), a metal-polymer composite,ceramics, combinations thereof, and the like, or other suitablematerial. Some examples of suitable polymers may includepolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), high density polyethylene (HDPE),polyester, Marlex high-density polyethylene, Marlex low-densitypolyethylene, linear low density polyethylene (for example REXELL®),ultra-high molecular weight (UHMW) polyethylene, polypropylene,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polypraraphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP).

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

In at least some embodiments, portions or all of the medical device 10may also be doped with, made of, or otherwise include a radiopaquematerial. Radiopaque materials are understood to be materials capable ofproducing a relatively bright image on a fluoroscopy screen or anotherimaging technique during a medical procedure. This relatively brightimage aids the user of the medical device 10 in determining itslocation. Some examples of radiopaque materials can include, but are notlimited to, gold, platinum, palladium, tantalum, tungsten alloy, polymermaterial loaded with a radiopaque filler, and the like. Additionally,other radiopaque marker bands and/or coils may also be incorporated intothe design of the medical device 10 to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the medical device 10. For example, themedical device 10 may include a material that does not substantiallydistort the image and create substantial artifacts (e.g., gaps in theimage). Certain ferromagnetic materials, for example, may not besuitable because they may create artifacts in an MRI image. The medicaldevice 10 may also be made from a material that the MRI machine canimage. Some materials that exhibit these characteristics include, forexample, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003such as ELGILOY®, PHYNOX®, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nitinol, and the like, and others.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The disclosure's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A system for delivering an implantable medicaldevice, comprising: a handle member including a seal assembly, whereinthe seal assembly is disposed within the handle member, and wherein theseal assembly includes: a turnbuckle assembly including a stationarymember and a cap coupled to the stationary member; wherein thestationary member is coupled to an inner member; wherein the cap iscoupled to an exoskeleton that includes a plurality of discrete segmentsengaged with one another disposed along an outer surface of the innermember; and wherein the cap is designed to shift distally relative tothe stationary member whereupon the exoskeleton is put in compression.2. The system of claim 1, wherein the cap is threadedly engaged with thestationary member.
 3. The system of claim 1, further comprising ahypotube positioned along the inner member, wherein the hypotube ispositioned between the cap and the exoskeleton.
 4. The system of claim3, wherein the cap includes a protrusion configured to engage a proximalportion of the hypotube.
 5. The system of claim 3, wherein the capincludes a first seal, and wherein the first seal is disposed along anouter surface of the hypotube.
 6. The system of claim 1, wherein thestationary member includes a distal tip region configured to engage aproximal portion of the inner member.
 7. The system of claim 1, whereinthe stationary member includes a recessed region, and wherein therecessed region is designed to mate with a protrusion in the handlemember.
 8. The system of claim 1, wherein the stationary member isconfigured to prevent the inner member from shifting with respect to thehandle member.
 9. A system for delivering an implantable medical device,comprising: a deployment sheath; an inner member disposed within aportion of the deployment sheath; and a handle coupled to the deploymentsheath, wherein the handle includes a seal assembly disposed within thehandle, and wherein the seal assembly includes: a first actuatingassembly, wherein the first actuating assembly is configured to receivethe deployment sheath; a second actuating assembly, wherein the secondactuating assembly is configured to receive an actuating shaft; and aturnbuckle assembly including a cap and a stationary member; wherein theturnbuckle assembly is configured to compress an exoskeleton positionedalong the inner member.
 10. The system of claim 9, wherein the cap isdesigned to shift distally with respect to the stationary member. 11.The system of claim 10, wherein the exoskeleton includes a plurality ofdiscrete segments engaged with one another, and wherein shifting the capdistally compresses the exoskeleton together.
 12. The system of claim10, wherein the cap is threadedly engaged with the stationary member.13. The system of claim 11, further comprising a hypotube positionedalong the inner member, wherein the hypotube is positioned between thecap and the exoskeleton.
 14. The system of claim 13, wherein the capincludes a protrusion configured to engage a proximal portion of thehypotube.
 15. The system of claim 13, wherein the cap includes a firstseal, and wherein the first seal is disposed along an outer surface ofthe hypotube.
 16. The system of claim 10, wherein the stationary memberincludes a distal tip region configured to engage a proximal portion ofthe inner member.
 17. The system of claim 10, wherein the stationarymember includes a recessed region, and wherein the recessed region isdesigned to mate with a protrusion in the handle.